FAST has collaborated with experts to create a renewed and expanded guidebook for developing Advanced Therapy Medicinal Products (ATMPs) in the Netherlands. Tailored to both academic and commercial developers, the guidebook delivers essential guidance on European and Dutch regulations and provides a roadmap to navigate the complex ATMP development process.
A guide to the ATMP landscape
The guidebook is the result of close collaboration with key partners, including the Dutch Medicines Evaluation Board (CBG), Hollandbio, DARE-NL, VIG, and input from over 25 experts. Building on the foundation of the VIG’s earlier guidebook, this updated and expanded edition integrates the latest insights, regulations, EMA processes, and advances in clinical research. With its practical tools and guidance, the handbook equips developers to handle complex procedures such as marketing authorization and reimbursement applications more effectively.
Patient-centered approach and collaboration
The guidebook underscores the value of early engagement with patient organizations and provides tools to facilitate this meaningful collaboration. It also emphasizes the importance of early engagement with stakeholders, such as the EMA, CBG, and the National Health Care Institute (ZIN). These collaborations contribute to faster patient access to ATMPs and long-term financial sustainability.
Structure of the guidebook
The guidebook is divided into three sections:
- Part 1 covers key lessons and offers guidelines for patient involvement.
- Part 2 provides background information and legal frameworks essential for ATMP development.
- Part 3 offers a detailed overview of the entire ATMP development pathway, from preclinical research to practical implementation.
Support and advice
Finally, the guidebook includes an overview of available support and relevant legislation. Developers are encouraged to seek advice from experts and centres of expertise, such as FAST and DARE-NL, early in the development process to simplify the path to market and minimize obstacles.
This guidebook is a valuable resource for everyone active in the rapidly growing ATMP sector, aligning with FAST’s mission to accelerate the delivery of innovative therapies to patients. In the spring of 2025, FAST, together with its partners, will host a series of webinars to present case studies and provide deeper insights into various sections of the guidebook.